Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial
Jason Gardosi, Lauren Ewington, Katie Booth, Debra Bick, George Bouliotis, Emily Butler, Sanjeev Deshpande, Hanna Ellson, Joanne Fisher, Adam Gornall, Ranjit Lall, Hema Mistry, Seyran Naghdi, Stavros Petrou, Anne‐Marie Slowther, Sara Wood, Martin Underwood, Siobhan Quenby
Abstract
BACKGROUND: The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care. METHODS: weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting. FINDINGS: weeks' gestation. In the per-protocol analysis, 27 (2·3%) of 1180 babies in the induction group versus 40 (3·7%) of 1074 in the standard care group had shoulder dystocia (RR 0·62 [0·41-0·92]; p=0·019), and there was a mean difference of -8·1 days' (-8·4 to -7·9) gestation and -213·3 g (-242·0 to -184·6) birthweight between trial groups. One neonatal death occurred from perinatal asphyxia after shoulder dystocia in the standard care group, and one neonatal death occurred following sepsis and congenital pneumonia in the induction group. 88 (6·1%) of 1447 mothers in the induction group had an adverse event versus 108 (7·5%) of 1446 in the standard care group (RR 0·81 [0·62 to 1·06]; p=0·13). Similar numbers of serious adverse events were reported in both groups. INTERPRETATION: weeks' gestation did show a significant reduction in shoulder dystocia. This study provides pregnant women with suspected LGA fetuses and their clinicians important information about choices and decision making for timing and mode of birth. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.